Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance - Full Text View

Sponsor:	University of California, San Francisco
Collaborator:	The University-Wide AIDS Research program
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187551

Purpose

The goal of this study is to examine whether enfuvirtide (T20, Fuzeon) has continued anti-HIV activity in patients experiencing an incomplete virologic response to an enfuvirtide-based regimen.

Condition	Intervention	Phase
HIV Infections	Other: Interruption of enfuvirtide Other: enfuvirtide interrupton	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Partial Treatment Interruptions in HIV-1 Patients With Multi-Drug Resistant Virus

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

CD4 [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]

Enrollment:	25
Study Start Date:	May 2000
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
interruption of enfuvirtide: Experimental enfuvirtide interruption	Other: Interruption of enfuvirtide treatment interruption Other: enfuvirtide interrupton enfuvitide will be interrupted in patients harboring resistant virus

Detailed Description:

Some patients do not achieve an undetectable HIV viral load with an enfuvirtide (T20, Fuzeon) based antiretroviral regimen. As a consequence, enfuvirtide resistant virus can emerge. It is not yet known if enfuvirtide has continued virologic or immunologic benefit after the drug-resistant variant emerges. Interrupting enfuvirtide may reduce the accumulation of enfuvirtide mutations and may allow for a potent response of enfuvirtide with future regimens.

Subjects must have evidence of viral replication (HIV RNA > 1,000 copies/ml on two consecutive measurements) while on a stable antiretroviral regimen containing enfuvirtide. Patients will then interrupt enfuvirtide while continuing all other antiretroviral agents. Subjects will be seen weekly for four weeks, every two weeks for an additional 8 weeks, and then every four weeks through week 48.

Plasma HIV RNA levels and CD4+/CD8+ T cell counts will be measured in real time at each visit, and provided to the referring primary care physician. Subjects will be allowed to resume enfuvirtide at any time during the course of this study. Subjects will be encouraged to resume enfuvirtide (with or without modifying the background regimen) if plasma HIV RNA levels increase by > 0.5 log on two consecutive occasions. Subjects are seen every four weeks for 24 weeks after enfuvirtide is resumed.

Plasma will be collected at those visits for HIV RNA and stored for retrospective genotype/phenotype evaluation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Currently receiving continuous enfuvirtide-based antiretroviral therapy.
Documentation of recent plasma HIV RNA level greater than the lower limit of detection (measured within the preceding 4 weeks)
Screening plasma HIV-1 RNA level > 1000 copies/mL.
Negative serum pregnancy test (for women of childbearing potential) documented within the 14-day period prior to study entry.
Subjects must be able to give written informed consent and agree to abide by the requirements of the study.

Exclusion Criteria:

Unstable HIV disease status such that interrupting any antiretroviral therapy poses significant short-term risk for disease progression (as determined by study investigators and referring primary care provider).
Female subjects who are pregnant, breastfeeding, or who plan to become pregnant during the study.
Active hepatitis C infection requiring treatment with an interferon-based regimen.
Evidence of active, untreated opportunistic infections or unexplained temperature which is > 38.5°C for seven consecutive days, within 30 days prior to the first screening visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187551

Locations

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

The University-Wide AIDS Research program

Investigators

Principal Investigator:

Steven G Deeks, M.D.

University of California, San Francisco

More Information

No publications provided

Responsible Party:	UCSF ( Steven Deeks )
Study ID Numbers:	H8211-18804-05
Study First Received:	September 13, 2005
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00187551 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

enfuvirtide
T20
Fuzeon
Treatment
Interruption
Resistance

HIV Drug Resistance
Antiretroviral Agents
Salvage Therapy
Drug Resistance, Multiple
Human Immunodeficiency virus

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Enfuvirtide
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on November 30, 2009